Urica Therapeutics Subsidiary Crystalys Doses First Patients in Phase 3 Gout Trials

Urica Therapeutics, a subsidiary of Fortress Biotech, announced that Crystalys Therapeutics has dosed the first patients in its Phase 3 trials for dotinurad, a treatment for gout. The RUBY and TOPAZ studies will evaluate the safety and efficacy of dotinurad compared to allopurinol in adults with hyperuricemia associated with gout and tophaceous gout, respectively. The trials aim to establish dotinurad as a potential best-in-class treatment for gout.

Urica Therapeutics, a subsidiary of Fortress Biotech (NASDAQ: FBIO), has announced that Crystalys Therapeutics has dosed the first patients in its global Phase 3 trials for dotinurad, a potential treatment for gout. The trials, named RUBY (NCT07089875) and TOPAZ (NCT07089888), aim to evaluate the safety and efficacy of dotinurad compared to allopurinol in adults with hyperuricemia associated with gout and tophaceous gout, respectively Fortress Biotech and Subsidiary Urica Therapeutics Announce First Patients Dosed in Crystalys Therapeutics’ Global Phase 3 Trials of Dotinurad for the Treatment of Gout^[1].

The RUBY study, a Phase 3, randomized, double-blind, multicenter trial, will enroll approximately 500 patients with hyperuricemia associated with gout. Participants will receive dotinurad orally once a day for up to 64 weeks. The TOPAZ study, also a Phase 3, randomized, double-blind, multicenter trial, will enroll approximately 250 patients with tophaceous gout. Participants will receive dotinurad orally once a day for up to 76 weeks Fortress Biotech and Subsidiary Urica Therapeutics Announce First Patients Dosed in Crystalys Therapeutics’ Global Phase 3 Trials of Dotinurad for the Treatment of Gout^[1].

Dotinurad is a next-generation, once-daily oral URAT1 inhibitor with potential for best-in-class safety and efficacy for the treatment of gout. The trials aim to establish dotinurad as a potential best-in-class treatment for gout, addressing a critical unmet need in the market Fortress Biotech and Subsidiary Urica Therapeutics Announce First Patients Dosed in Crystalys Therapeutics’ Global Phase 3 Trials of Dotinurad for the Treatment of Gout^[1].

Urica Therapeutics holds a minority equity stake in Crystalys and is eligible for a 3% royalty on future dotinurad sales. The announcement also highlights recent corporate milestones, including two U.S. FDA approvals and a transaction with Sun Pharma that generated aggregate payments near $355 million plus a $60 million CVR structure, from which Fortress received roughly $28 million upfront and may receive an additional $4.8 million and a 2.5% royalty on future UNLOXCYT sales Fortress Biotech and Subsidiary Urica Therapeutics Announce First Patients Dosed in Crystalys Therapeutics’ Global Phase 3 Trials of Dotinurad for the Treatment of Gout^[1].

The initiation of these pivotal clinical trials marks an important milestone for Fortress, building on the significant momentum achieved over the past year. The development program’s value hinges on achieving positive Phase 3 efficacy and safety outcomes and subsequent regulatory approvals; initiation alone carries scientific and regulatory risk and does not guarantee approval or revenue Fortress Biotech and Subsidiary Urica Therapeutics Announce First Patients Dosed in Crystalys Therapeutics’ Global Phase 3 Trials of Dotinurad for the Treatment of Gout^[1].

Investors should watch for enrollment milestones, predefined primary endpoint readouts, and any disclosed timelines for topline data or regulatory filings over the next 12–36 months, as these will determine whether the program moves from developmental value to commercial value realization Fortress Biotech and Subsidiary Urica Therapeutics Announce First Patients Dosed in Crystalys Therapeutics’ Global Phase 3 Trials of Dotinurad for the Treatment of Gout^[1].